SOLTI-1904 ACROPOLI TRIAL: efficacy of spartalizumab monotherapy across tumor-types expressing high levels of PD1 mRNA
FUTURE ONCOLOGY(2022)
摘要
Improved selection of cancer patients who are most likely to respond to immune checkpoint inhibitors remains an unmet clinical need. Recently, a positive correlation between levels of PD1 mRNA and clinical outcome in response to PD1 blockade across diverse tumor histologies has been confirmed in several datasets. ACROPOLI is a parallel cohort, non-randomized, phase II study that aims to evaluate the efficacy of the anti-PD1 immune checkpoint inhibitor spartalizumab as monotherapy in metastatic patients with solid tumors that express high levels of PD1 (cohort 1; n = 111). An additional cohort of 30 patients with tumors expressing low levels of PD1, where PD1/PD-L1 antibodies in monotherapy are standard treatment, will also be included (cohort 2). Primary end point is overall response rate in cohort 1. Considering previous data, we hypothesized that anti-PD1 monotherapy is effective across multiple cancer types in patients with PD1-high mRNA expressing tumors. Given these observations, ACROPOLI is a phase II study designed to study spartalizumab in this population. This article describes the SOLTI-1904 ACROPOLI phase II trial, `Efficacy of spartalizumab across multiple cancertypes in patients with PD1-highmRNA expressing tumors defined by a single and pre-specified cutoff.' The primary objective is to determine overall response rate (ORR) in the PD1-high population. Secondary objectives include other measures of clinical efficacy and evaluation of safety and tolerability. Spartalizumab has shown to have a manageable safety profile and preliminary clinical efficacy according to several phase I/II clinical trials [1-3].
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关键词
immunotherapy, metastatic cancer, PD-1, spartalizumab
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